Identity
- Trade Name
- SPE1-Y7 EUDAMED
- Device Name
- SPE1-Y-Series EUDAMED
- Model / Reference
- SPE1-Y7 EUDAMED70100146823 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503021977 EUDAMED
- Basic UDI-DI
- B-04044503021977 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spe1-Y7 by FUJIFILM medwork GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04044503021977 | Class I | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED e3374a44-d442-4a48-bdce-16a653b066f1 61 fields · synced Jun 20, 2026